Deeming Regulations have been released!!!!

[DC2]

I wasnt, I suspected so, but damn, they invented a whole new language when they wrote this stuff.

This is, generally speaking, the part where they crush the industry...
Premarket Tobacco Applications

How Do I Demonstrate that the New tobacco Product Is Appropriate for the Protection of Public Health?
Premarket tobacco Applications must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users. This demonstration shall take into account the increased or decreased likelihood that existing tobacco users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.

A pretty new paint job?
Good luck with that.

 

[Bea-FL]

Product listing has always been due December 31st.
VTA Guidance - Deeming Compliance Calendar - FINAL.pdf

Hmmm, then either she misunderstood him or I misunderstood her because she seemed to think he was releaved to have that extension.

 

[Lessifer]

Hmmm, then either she misunderstood him or I misunderstood her because she seemed to think he was releaved to have that extension.

I've seen many vendors misunderstand the various deadlines. It's not as if the FDA has made any of this easy.

 

[ENAUD]

and the only positive conclusion I can draw is that we are screwed. Now its just a matter of "how bad".

The term carpet bombed comes to mind...

 

[skoony]

I've seen many vendors misunderstand the various deadlines. It's not as if the FDA has made any of this easy.

Since the deeming regs have come to pass I have seen some posts from supposed owners
that lead me to believe that some haven't read or if they have read them do not
understand the regulations. There are a few who claim to have the advice of
legal council. Not saying anyone here is less than truthful but, the general
impression I get from reading post's across the forums is a some vendors
are just leading on their customers.
" Don't worry we have been preparing for this for some time. Rest assured
me and my staff are on top of this."(typical response to specific questions concerning
what they are doing to prepare)

Regards
Mike

 

[WillyZee]

The road to surviving the regs and staying in business?

Submit PMTAs


Sent via iPhone

 

[Lessifer]

The road to surviving the regs and staying in business?

Submit PMTAs


Sent via iPhone

 

[Lessifer]

The road to surviving the regs and staying in business?

Submit PMTAs


Sent via iPhone

I haven't seen much discussion about it on this board, but I know some vendors think they'll be able to stall by submitting something for the PMTA process. Hoping that it will be tied up in backlogs long enough to keep them in business for another year or so. Then the FDA announced their plans for a preliminary screening process for PMTAs, so they can quickly identify and reject incomplete applications.

 

[r055co]

Since the FDA loves to support their Big Pharma masters with our tax dollars, they're hiring kids to conduct entrapment operations

Here comes the underage Purchasers to your vape shops • /r/electronic_cigarette

Sent from my Nexus 6 using Tapatalk

 

[BreSha6869]

I thought this was great.....

I recieved a mech mod from FT today and I laughed when I saw the "electronics parts" package from "Kayleigh" valued at $5 and marked as a gift contained the mod in this packaging....

 

[Icemanxxxv]

I thought this was great.....

I recieved a mech mod from FT today and I laughed when I saw the "electronics parts" package from "Kayleigh" valued at $5 and marked as a gift contained the mod in this packaging....

Ain't no way to stop the Chinese [emoji12]

Sent from my SM-G900T3 using Tapatalk

 

[BreSha6869]

Ain't no way to stop the Chinese [emoji12]

Sent from my SM-G900T3 using Tapatalk

True dat!

 

[grandmato5]

I posted this in another thread discussing this same issue:
The way the regs are written, yes. However, if it went to court, I think it could be argued that it is not a new product based on the recent ruling by judge Mehta in the case brought forward by BT in which he decided that “a modification to an existing product’s label does not result in a new tobacco product, and therefore such a label change does not give rise to the act's substantial equivalence review process.”

In one of the question and answer sessions I watched (like 15 times to figure out what they were really saying ) The question was asked if a change to a label would require a new PMTA. They used the word "branding" several times in relationship to knowing if a change would require a new PMTA. If the label change would cause the customer to see it as a different product then it would need a new PMTA. If the chance was minimal enough that the customer wouldn't think of it as being a different product then no PMTA required. What I heard them say in the Q & A definitely was different then what I had previously seen written by them.

 

[WillyZee]

Ain't no way to stop the Chinese [emoji12]

Sent from my SM-G900T3 using Tapatalk

True dat!

nothing's going to stop The Pacific Mall

 

[Lessifer]

In one of the question and answer sessions I watched (like 15 times to figure out what they were really saying ) The question was asked if a change to a label would require a new PMTA. They used the word "branding" several times in relationship to knowing if a change would require a new PMTA. If the label change would cause the customer to see it as a different product then it would need a new PMTA. If the chance was minimal enough that the customer wouldn't think of it as being a different product then no PMTA required. What I heard them say in the Q & A definitely was different then what I had previously seen written by them.

The way they are written, any change other than one required by law would require an SE application at minimum. The recent ruling for cigarettes, if I'm reading it correctly, says that if the only change is to the label, then it does not require an SE application. I'm not sure if there are appeals in the works for that, or if it will automatically spur a change in the regulations for newly deemed tobacco products. I just like that the judge basically said "changing the package does not constitute a change to the product."

 

[BreSha6869]

nothing's going to stop The Pacific Mall

Ooohhhhh... passing by there tomorrow.... might have to stop in for a big pile of $3.99 noodles.

For those that have no idea what we are talking about, it is a huge Chinese mall just north of Toronto in Markham.

 

[WillyZee]

Ooohhhhh... passing by there tomorrow.... might have to stop in for a big pile of $3.99 noodles.

For those that have no idea what we are talking about, it is a huge Chinese mall just north of Toronto in Markham.

The largest Chinese mall in North America ... gotta go to China to find bigger.


Sent via iPhone

 

[BreSha6869]

The largest Chinese mall in North America ... gotta go to China to find bigger.


Sent via iPhone

Yup. Anyone into cell phones, sunglasses, electronics and Hello Kitty would have sensory overload as soon as they walked in.

 

[Bea-FL]

This is what these regs have done to my local B&M and it is really hurting their bottom line because service was a big part of what they offer. So sad

 

[jpasint]

View attachment 593255 View attachment 593257 This is what these regs have done to my local B&M and it is really hurting their bottom line because service was a big part of what they offer. So sad

This really breaks my heart to see, truly.

Freaking government bureaucrat $%&@$&%$$......